Study of efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsing forms of multiple sclerosis

Phase 1

• Conditions: multiple sclerosis; MedDRA version: 19.0Level: PTClassification code 10048393Term: Multiple sclerosis relapseSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2015-005418-31-HU
• Lead Sponsor: ovartis Pharma AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-07-08
• Last Update Posted: 10 August 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 900

Inclusion Criteria

•Male or female patients aged 18 to 55 years (inclusive) at screening
•Diagnosis of MS according to the 2010 Revised McDonald criteria
•Relapsing form of MS: relapsing-remitting course (RRMS), or secondary progressive course with disease activity (relapsing SPMS)
•Disability status at Screening with an EDSS score of 0 to 5.5 (inclusive)
•At least 1 documented relapse during the previous 1 year OR at least 2 documented relapses during the previous 2 years OR a positive GdE MRI scan during the year prior to randomization and including screening.
•Neurologically stable within 1 month prior to randomization

Please see protocol for complete detailed list of inclusion criteria
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 900
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Patients with primary progressive MS or SPMS without disease activity
•Disease duration of more than 10 years in patients with EDSS score of 2 or less
•Pregnant or nursing (lactating) women
•Women of child-bearing potential not using highly effective contraception
•Patients with an active chronic disease
•Patients with active systemic infections, or history of or known presence of recurrent or chronic infection
•Have received any live or live-attenuated vaccines within 2 months prior to randomization
•Have been treated with medications as specified within the timeframes specified (e.g. ofatumumab, rituximab, ocrelizumab, alemtuzumab, natalizumab, cyclophosphamide, teriflunomide, etc)
•Any other disease or condition which could interfere with participation in the study according to the study protocol, or with the ability of the patients to cooperate and comply with the study procedures.

Please see protocol for complete detailed list of exclusion criteria

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified